Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis

NCT03325868 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Ulipristal
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Adenomyosis affects approximately 21% of symptomatic women who present to gynecology clinics. The disease is characterized by heavy bleeding and pain during periods. Limited treatment options exist for the treatment of adenomyosis for women who desire future child-bearing or prefer to avoid surgery. Recently, ulipristal acetate has been studied as a treatment option for women who have fibroids and heavy bleeding. The majority of women treated with ulipristal stopped having periods altogether. Our study aims to determine whether ulipristal is an adequate treatment for women with adenomyosis.

Conditions

Adenomyosis; Heavy Uterine Bleeding; Dysmenorrhea

Keywords

heavy periods, painful periods, adenomyosis

Outcome Measures

Primary Outcomes (1)

• Bleeding patterns

  Patient will use the pictorial blood loss assessment chart (PBAC) to describe bleeding patterns

  6 months

Secondary Outcomes (2)

• Quality of life

  6 months

• Pain

  6 months

Study Arms (1)

Ulipristal

EXPERIMENTAL

Ulipristal acetate 5mg daily for 12 weeks

Drug: Ulipristal Acetate

Interventions

Ulipristal Acetate DRUG

Ulipristal 5mg daily by mouth for 12 weeks

Also known as: Fibristal

Ulipristal

Eligibility Criteria

• Age: 18 Years - 51 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• PBAC score greater than 100
• Ultrasound or MRI findings of adenomyosis

You may not qualify if:

• Inability to comprehend written and/or spoken English or Spanish
• Inability to provide informed consent
• Current uterine, breast, cervical or ovarian cancer
• Unwilling to use contraception
• Positive pregnancy test or planning pregnancy during the study period
• Submucosal uterine fibroids (or greater than a certain size)
• Current premalignancy or malignancy
• Endometrial ablation or uterine artery embolization
• Known hemoglobinopathy
• Known severe coagulation disorder
• Large uterine polyp (\>2cm)
• BMI \>40
• Previous or current treatment with SPRM or GnRH agonist
• Progestins, acetylsalicylic acid, mefenamic acid, anticoagulants, antifibrinolytic drugs, systemic glucocorticoids within 1 month of enrollment

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Adenomyosis; Dysmenorrhea; Menorrhagia

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Hemorrhage; Hemorrhage

Study Officials

• Amanda Yunker, DO

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: February 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)